Kornimate/medical-research-clean huggingface dataset:
brain monitoring for high risk of brain metastases in metastatic breast cancer

Conditions: Metastatic Breast Cancer With HER2 Positive; Triple Negative Breast Cancer

Summary: in general, brain metastases found after development of neurologic symptoms have poor prognosis. therefore, the investigators aim to investigate whether regular brain mri (magnetic resonance imaging) can detect early brain metastases and influence survival through early brain management in her2-positive and triple negative breast cancer.

it is well known that her2-receptor positive and triple negative metastatic breast cancer (mbc) have poor prognosis than hormone receptor positive metastatic breast cancer. however, as new therapies such as trastuzumab and pertuzumab are introduced, overall survival was extended in patients with metastatic breast cancer compared with the previous 10 years. as a result, the number of breast cancer patients with brain metastases has increased, the demand for treatments of brain metastases is increasing. the incidence of brain metastases in mbc has been reported to be 7.6% and 10.8% in luminal a / b, respectively. however, her2-positive and triple negative breast cancer with the incidence of more than 30% of brain metastases were at high risk group of brain metastases. in general, brain metastases found after development of neurologic symptoms have poor prognosis. therefore, the investigators aim to investigate whether regular brain mri (magnetic resonance imaging) can detect early brain metastases and influence survival through early brain management in her2-positive and triple negative breast cancer.

Eligibility criteria:
inclusion criteria: * patients over 19 years * pathologically documented breast cancer that: 1. is unresectable or metastatic ; 2. has confirmed her2 positive expression according to american society of clinical oncology- college of american pathologists (asco-cap) guidelines or triple negative breast cancer * no prior systemic palliative treatment of metastatic breast cancer * must have provided informed consent for study participation before performance of any study-specific procedures or tests exclusion criteria: * history of prior treatments about brain metastases or leptomeningeal metastases * symptomatic brain metastases at screening period * has received more than second-line systemic treatments (including endocrine therapy) * for subjects who have difficulty lying down or who have claustrophobia, they can undergo sedation during brain mri * history of hypersensitivity reaction to contrast or drug allergic reaction * patients who inserted metallic prosthesis (pacemaker, denture, hearing aid, aneurysm clip, metallic material of eyeball, artificial joint, insulin pump, chemo-port, temporary tissue expander for breast reconstruction, etc) can be conducted after consultation with investigator before mri. * has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. * social, familial, or geographical factors that would interfere with study participation or follow-up

Keywords: breast cancer brain metastases screening brain mri
impact of covid-19 pandemic on allogeneic stem cell transplantation organization : a french experience

Conditions: Allogeneic Stem Cell Transplantation; SARS-CoV2 Infection; COVID-19

Summary: the sars-cov2 pandemic has led to a major reorganization of the french hematology and stem cell transplant departments since march 2020. since the allogeneic stem cell transplant cannot be delayed especially when patients with hematological malignancies are in a fragile remission, risking relapse at any time, the necessity to maintain safe hematopoietic stem cell (hsc) donations from match unrelated or family donors appears rapidly mandatory during the pandemic period. to increase the safety of voluntary donations, a sars-cov2 polymerase chain reaction test has been recommended to donors by regulatory agencies. however, due to the lack of homogeneity of care at european level, some countries do not require sars-cov-2 testing in asymptomatic donors. in this case, the test is performed on additional edta tube accompanying the graft on arrival or in the case of a missing tube (not collected or forgotten), on few milliliters of the hsc graft. this circuit had the consequence of forcing the clinicians to wait for the test result before starting the patient's conditioning regimen. the graft being already collected and received at the transplant center, and the conditioning regimen lasting on an average of 5 days, this resulted in its conservation during this minimum period and therefore its freezing by the associated cell therapy unit. however, this practice has so far been exceptional regarding allogeneic transplants, which are primarily freshly infused to ensure to the recipient the highest viability and functionality of stem cells. since the entire freezing-thawing and washing process may impact cell viability and delay the patient's aplastic recovery, this study aimed to analyze the results of one year of allogeneic transplants infused after freezing in terms of graft quality after thawing and clinical consequences.


Eligibility criteria:
inclusion criteria: * patients receiving an allogeneic stem cell transplant between march 2020 and may 2021. exclusion criteria: * patients receiving an allogeneic stem cell transplant before march 2020 and after may 2021.

Keywords: allogeneic stem cell transplant sars-cov2 freezing process
the arctic trial: aerosolized inhaled adenosine treatment in patients with acute respiratory distress syndrome (ards) caused by covid-19

Conditions: Acute Respiratory Distress

Summary: this is a phase ii study to test adenosine efficacy for down-regulation of the overwhelming inflammation of covid-19 in the lungs as reflected by clinical recovery of lung function; resolution of clinically relevant markers of lung function, and resolution of systemic markers of inflammation and coagulation.


Eligibility criteria:
inclusion criteria: * adult (≥ 18 years old) male and female patients with diagnosed covid-19 respiratory infection, verified by culture/swab rna. impending ards respiratory collapse with progressive increasing oxygen requirements, and in line with sub-study as defined below. * patients intubated within the prior 24 hours. * hemodynamically stable (not requiring vasopressors or catecholamine agents to support systemic blood pressure; no existing shock defined as bp \< 100 mmhg systolic). * in-place continuous arterial line for blood sampling. exclusion criteria: * younger than 18 years old. * prisoners * pregnant women. * unable to obtain next of kin consent. * end-stage cardiac disease with covid-19. * non covid-related causes of ards/respiratory failure, septic shock, or post trauma shock, respiratory failure after blood transfusion or surgery. * unstable asthma or history of frequent/poorly controlled asthmatic attacks. * not expected to live more than 6 months due to underlying condition such as cancer.

Keywords: covid-19 ards adenosine
the efficacy and safety of iron supplementation

Conditions: Healthy

Summary: each year, 5 million packs of iron tablets are dispensed in england and wales to treat anaemia due to iron deficiency. iron tablets are not always easy to take. the investigators think that there could be ways to reduce the number of iron tablets needed, by increasing the dietary intake of iron. in this study the investigators will assess the efficacy and safety of a dietary iron supplement compared to iron tablets using controls and new biomarkers.

18 healthy individuals will be randomised to one of three arms, and for two consecutive mornings, will receive either an iron tablet (ferrous sulphate 200mg), a dietary iron supplement, or no agent. blood and urine samples will be collected pre-dose, and at stated intervals 2.5, 4, 7, 24 and 48 hours post first dose. the standard deviations of data obtained in this pilot study will be used to perform power calculations for our future studies in this field.

Eligibility criteria:
inclusion criteria: to be a healthy, consenting volunteer not currently receiving iron supplements. exclusion criteria: 1. needle phobia 2. currently receiving iron supplements 3. unable to provide informed consent

Keywords: volunteers pilot study there are no pre registration evaluations. inclusion criteria: to be a healthy, consenting volunteer not currently receiving iron supplements. exclusion criteria: 1) needle phobia; 2) currently receiving iron supplements; 3) unable to provide informed consent
arkansas expanded access covid-19 convalescent plasma treatment program

Conditions: COVID-19

Summary: this is an expanded access treatment protocol to treat up to 100 patients with severe or life-threatening, laboratory confirmed covid-19 with covid-19 convalescent plasma.

this is an expanded access treatment protocol to treat up to 100 subjects with severe or life-threatening, laboratory confirmed covid-19 with covid-19 convalescent plasma. subjects will receive 1-2 units (200-400 ml per unit, not to exceed 550 ml total) of abo compatible, low isohemagglutinin titer, covid-19 convalescent plasma. plasma will be administered one unit per day for up to two days. the duration of infusion will usually take 1 to 2 hours (rate of 100 to 250 ml/hr). the infusion should not exceed 4 hours. plasma infusions will be administered following standard institutional procedures, including the use of premedications (e.g. acetaminophen, diphenhydramine, etc.) as necessary.

Eligibility criteria:
inclusion criteria: * male or female * 18 years of age or older * laboratory confirmed covid-19 via sars-cov-2 rt-pcr testing * patients currently hospitalized with severe or life-threatening covid-19 or patients the treating physician deems to be at high-risk for progressing to severe or life-threatening covid-19. * severe disease, defined as one or more of the following: * dyspnea, * respiratory frequency ≥ 30/min, * blood oxygen saturation ≤ 93%, * partial pressure of arterial oxygen to fraction of inspired oxygen ratio \< 300, and/or * lung infiltrates \> 50% within 24 to 48 hours * life-threatening disease, defined as one or more of the following: * respiratory failure, * septic shock, and/or * multiple organ dysfunction or failure * patients or their legally authorized representative must provide informed consent. exclusion criteria: * female patients with positive pregnancy test, breastfeeding, or planning to become pregnant/breastfeed during the study period. * patients who have received pooled immunoglobulin in past 30 days * contraindication to transfusions or history of prior reactions to transfusion blood products
investigation of the effect of 8-week controlled high intense interval training in type 2 diabetic patients

Conditions: Type 2 Diabetes

Summary: the overall objective of this study is to examine the blood flow in the thigh muscles and sugar metabolism before and after 8 weeks of high intensity interval training (hiit) on a bicycle ergometer in patients with type 2 diabetes (t2d) and matched controls. the following parameters are included in the assessment: * sugar metabolism * muscle and fat mass * the blood flow at rest around the thigh muscles * oxygen uptake test on a bicycle ergometer and 5 km time trial

type 2 diabetes (t2d) can be defined as a bihormonal metabolic disorder characterised by insufficient insulin secretion and abnormal glucagon secretion. it is however well established that physical activity per se improves glucose and may postpone or even slow down in the diabetic population. glycaemic control may be improved more by high intensity interval training than by intensities from existing recommended guidelines. additionally, there seems to be accumulating evidence that high intensity interval training induces increased overall fat and abdominal fat mass loss as opposed to traditional continuous endurance training therefore we hypothesise that 3 weekly sessions of high intensity interval training (10×60 sec. at an intensity inducing 90% of maximal heart frequency with a recovery of 60 sec. between each bout) over 8 weeks improves overall glycaemic control (glucose, insulin and glucagon), inflammatory status (interleukins, cytokines, chemokines and cell adhesion molecules) and blood flow (no and pgi2 vasodilatory capabilities).

Eligibility criteria:
inclusion criteria: * type 2 diabetes or matched healthy controls. t2d subject only : hba1c \> 7,3. all subjects have an age between 40-65 years and a body mass index between 25-40 kg/m2. both genders is allowed exclusion criteria: * severe diseases /immobility

Keywords: type 2 diabetes interval training insulin resistance fat metabolism
ostom-i alert sensor quality of life validation

Conditions: Ostomy

Summary: the purpose of this study is to determine the usability and acceptance of the ostom-i alert sensor. the investigators would like to see if is generally helpful to ostomy patients and whether it has a beneficial impact on living with an ostomy bag. results from this study will be used to determine if a larger clinical study is feasible.

evidence from clinical experience shows that patients with ostomies go through a significant life change to learn to live with the ostomy bag. these changes can include "an altered body image, changes in daily routines, and for some, changes in life patterns such as work and leisure activities" (burckhardt). previous studies have also shown that ostomy patients have negative changes in their physical, psychological, social, and spiritual quality of life (krouse). an ostomy patient developed the ostom-i alert sensor after experiencing these changes - the goal of the sensor is to make life easier for patients with ostomy bags, by allowing for easier output measurements and anticipation of bag changes. in this study, we hope to use this new device and track any improvements for quality of life for ostomy patients.

Eligibility criteria:
inclusion criteria: * 18-80 years of age * use of an ostomy bag for at least six months * must own an iphone, ipod touch, or android exclusion criteria: * use of large urostomy bags
non-dispense comfort comparison of two silicone hydrogel lenses

Conditions: Myopia

Summary: the purpose of this study is to compare subjective responses to two contact lenses after 15 minutes of wear.


Eligibility criteria:
inclusion criteria: * currently wearing soft contact lenses * replaces lenses on a weekly or longer schedule * other protocol-defined inclusion/exclusion criteria may apply exclusion criteria: * requires concurrent ocular medication * eye injury or surgery within twelve weeks immediately prior to enrollment * currently wearing soft toric lens wearers * those who dispose of their soft lenses on a daily basis * other protocol-defined inclusion/exclusion criteria may apply
pilot testing of food images in children

Conditions: Childhood Obesity; fMRI

Summary: this is a single, un-replicated visit to the children's metabolic kitchen and eating behavior lab designed to gather data on children's responses to images used in mri studies. additionally, a demographic questionnaire for parents will be piloted.

the pilot test session will take place in the children's metabolic kitchen and eating behavior lab in chandlee laboratory. up to four hundred subjects (200 children and 200 parents) may be recruited. child procedures: both child and parent's current height and weight will be obtained. after being seated at a computer, they will complete the children's anxiety meter-state (cams) and a freddy fullness pictorial hunger score. then their ability to discriminate between portion sizes will be assessed. they will be shown several pictures of macaroni and cheese on a standard white plate with a grey tablecloth background and asked to determine which picture had a larger amount of food. finally, they will view 180 pictures of common foods and non-food objects (office supplies). after each picture, children will be instructed to answer questions about the image (what is this image, how happy does it make you feel and how excited does it make you feel). children will then score their hunger again with a freddy fullness pictorial hunger score and take a post-scanning questionnaire. parent procedures: parent's current height and weight will be obtained and he/she will complete a demographic questionnaire.

Eligibility criteria:
inclusion criteria: * child is 6 to 10 years old * child is physically healthy and does not have a diagnosed learning disorder exclusion criteria: * child is \ 10 years old * child is not physically healthy or has a diagnosed learning disorder

Keywords: portion size effect childhood obesity fmri
assessing pancreatic fistula rates after distal pancreatectomy using aeon endostapler

Conditions: Pancreas; Fistula; Pancreas Cancer; Pancreatic Disease; Surgery-Complications; Surgery

Summary: this prospective, observational study evaluates the rate of postoperative pancreatic fistula (popf) following distal pancreatectomy (dp) using the aeon™ endostapler. the study involves 110 patients undergoing dp and assesses primary outcomes based on the international study group of pancreatic fistula (isgpf) classification, alongside secondary perioperative parameters. the findings aim to optimize surgical techniques, reduce complications, and improve healthcare outcomes.

this is a prospective, observational, monocentric study designed to evaluate the incidence of postoperative pancreatic fistula (popf) following distal pancreatectomy (dp) performed using the aeon™ endostapler. popf is one of the most serious complications after dp, and effective stump closure remains a critical challenge in reducing its occurrence. the study will involve 110 patients who meet the inclusion criteria and undergo dp at the university of heidelberg. primary outcomes will focus on the rate of clinically relevant popf as defined by the international study group of pancreatic fistula (isgpf). secondary outcomes include intraoperative and postoperative parameters, such as estimated blood loss, operation duration, icu and hospital stay, reoperation rates, and 90-day mortality. all outcomes will be assessed following standardized protocols. patients will be enrolled after providing informed consent and will receive follow-up evaluations at specific time points, including postoperative days 1, 3, 14, 30, and 90. amylase levels in drain fluid will be measured to monitor pancreatic leakage. data collected during the study will be analyzed to assess the effectiveness and safety of the aeon™ endostapler in reducing popf and other complications. the findings aim to contribute critical evidence to improve surgical practices and outcomes for dp patients, potentially shaping future guidelines and reducing healthcare costs.

Eligibility criteria:
inclusion criteria: * age 18 years or older. * ability to understand the nature and consequences of the study. * provision of written informed consent. * scheduled for minimally invasive or open distal pancreatectomy (dp) for any indication, with or without splenectomy and/or left adrenalectomy. exclusion criteria: * inability to comply with study procedures or follow-up. * multivisceral resection beyond left adrenalectomy. * history of previous pancreatic surgeries. * expected lack of compliance with the study protocol. * participation in another trial that may interfere with the intervention or outcomes of this study.
colchicine in periprocedural myocardial infarction: the role of alpha defensin

Conditions: Inflammation; Myocardial Infarction

Summary: the aim of this research is to study the effect of a loading dose of colchicine on the occurrence of periprocedural myocardial infarction (ppmi) in elective percutaneous coronary intervention.


Eligibility criteria:
inclusion criteria: * patients hospitalized with troponin negative events and scheduled for elective pci exclusion criteria: * significant renal dysfunction * significant liver dysfunction * severe left ventricular dysfunction * severe low weight * chronic colchicine treatment
an observational study looking at how well the drug eligard works and how well it is tolerated by the body of patients with advanced prostate carcinoma in the russian federation

Conditions: Advanced Prostate Carcinoma

Summary: eligard is a 6-month depot injection formulation that combines the active ingredient leuprorelin acetate (la) with a biodegradable polymer matrix (atrigel® delivery system). the 6-month (45 mg) formulation was approved for the russian market in 2009. it has been shown to reduce testosterone and prostate-specific antigen (psa) levels and to be well tolerated in several clinical trials. however, clinical trials are limited by strict patient inclusion and exclusion criteria. therefore, the current non-interventional study aimed at investigating whether the efficacy and tolerability of the 6-month la depot formulation could also be confirmed in a broad and heterogeneous patient population encountered in daily clinical practice in the russian federation. this study will evaluate total serum psa and testosterone levels, quality of life (qol) of patients, demographic patient data, diagnosis and diagnostic findings in patients. it will provide analysis in different subgroups of patients depending on previous hormonal treatment and anamnesis of disease.


Eligibility criteria:
inclusion criteria: * all male patients \> 18 years of age with advanced pca to whom oncourologist decided to prescribe eligard 45 mg exclusion criteria: * patient participation in any clinical trials.

Keywords: uro-oncologists psa eligard prostate carcinoma